Sciele's drooling drug meets Ph III endpoints
USA-based Sciele Pharma has completed a pivotal Phase III program to support a New Drug Application filing for glycopyrrolate liquid for use by pediatric patients with chronic, moderate-to-severe drooling as a result of cerebral palsy, mental retardation, or any other neurological condition. The open-label, 24-week, multi-center study met its primary endpoint, achieving a responder rate higher than placebo based on change in the modified Teacher's Drooling Scale as administered by parents and caregivers from baseline to week eight. The firm, which is in the process of being taken over by Japan's Shionogi (Marketletter September 8), says the Phase III program will supplement a US filing in fourth-quarter 2008.
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